510(k) · Cleared
ClearedMicrodl Diarycard Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Direct, Inc. · BZG Spirometer, Diagnostic
Cleared on Jun 17, 1997 as substantially equivalent to K963035 (Micro Direct, Inc., 1996) after a 182-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 17, 1997
- Review
- 182 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901057 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK901057 Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
- 1 generation backK963035 Micro SpirometerMicro Direct, Inc. · 1996
- This deviceK965042 Microdl Diarycard SpirometerMicro Direct, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK100928 Micro Diary SpirometerViasys Respiratory Care, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK113096 Micro ICarefusion Germany 234 GmbH · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901057 | Spirometrics Model 2600 Miro Spirometer | Spirometrics, Inc. | 1990 | — |
| −1 | K963035 | Micro Spirometer | Micro Direct, Inc. | 1996 | — |
| 0 (this device) | K965042 | Microdl Diarycard Spirometer | Micro Direct, Inc. | 1997 | — |
| +1 | K100928 | Micro Diary Spirometer | Viasys Respiratory Care, Inc. | 2011 | — |
| +2 | K113096 | Micro I | Carefusion Germany 234 GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963035 | Micro SpirometerSummary page 1…ame: Diagnbstic Spirometer Classification Name: 73 BZG - Diagnostic Spirometer Intended device: Diagnostic Spirometer Predicate devices: Micro Medical Micro Spirometer - K963035 Device description: A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF. Indicated use: The intended devic… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100928 | Micro Diary Spirometer | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K100928 (Viasys Respiratory Care, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K963035.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To measure lung functions. - FEV1, FVC, and PEF. and to effect historical serial transfer of measured test indices to PC compatible computers
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965042 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965042: Microdl Diarycard Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965042
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026